STORZ ANESTHESIA ADAPTER FOR BRONCHOSCOPES

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-12 for STORZ ANESTHESIA ADAPTER FOR BRONCHOSCOPES manufactured by Karl Storz Endoscopy-america, Inc..

Event Text Entries

[183120484] The patient was undergoing an elective cardiac cath and rigid bronchoscopy to assess for underlying conditions. During the bronchoscopy exam the equipment was unable to be attached to the ventilator system secondary to an incompatible adaptor. The patient became hypoxic, bradycardia and a code was called. The pals protocol was initiated, endotracheal tube was place, return of circulation occurred and the patient stabilized. By report, the general surgical provider attempted to utilize the connecting adaptor as indicated, but the size of the adaptor in the procedure kit did not allow for attachment of tubing to the ventilator. The adaptor should have a small end and a large end to secure into the system. This adaptor had two small ends allowing for leak of oxygen. The adaptor available is a re-usable adaptor. Storz anesthesia adapter for rigid bronchoscopes.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9823794
MDR Report Key9823794
Date Received2020-03-12
Date of Report2020-02-14
Date of Event2020-02-12
Report Date2020-02-28
Date Reported to FDA2020-02-28
Date Reported to Mfgr2020-03-12
Date Added to Maude2020-03-12
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSTORZ ANESTHESIA ADAPTER FOR BRONCHOSCOPES
Generic NameBRONCHOSCOPE ACCESSORY
Product CodeEOQ
Date Received2020-03-12
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerKARL STORZ ENDOSCOPY-AMERICA, INC.
Manufacturer Address2151 E. GRAND AVE EL SEGUNDO CA 90245 US 90245


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2020-03-12

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